Venous valve implanted in Canada as Venus Medtech enter North American market

15th June 2018

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First Clinical Implantation of Transcatheter Pulmonary Valve VenusP-Valve in North America was Successfully Performed in Vancouver, Canada (PRNewsfoto/Venus Medtech (Hangzhou) Inc.)

St Paul‘s Hospital in Vancouver, Canada has successfully completed two implantations of the VenusP-Valve (Venous Medtech), a self-expanding pulmonary valve. This is the first appearance of Venus Medtech’s transcatheter valve products in North America.

Although surgical treatment of congenital heart disease has evolved dramatically in recent decades, operations involving the right ventricular outflow tract can still result in chronic pulmonary regurgitation, necessitating either surgical or percutaneous pulmonary valve implantation.

Percutaneous pulmonary valve implantation has emerged as a successful alternative to surgical valve implantation in such patients. However, the currently available balloon-expandable percutaneous valves are suitable only for outflow tracts reconstructed with cylindrical surgical tubes. Treatment of pulmonary regurgitation in the setting of prior right ventricular outflow tract patch augmentation has traditionally been limited to surgical intervention. This is mainly due to the limited available sizes of balloon-expandable valves relative to often severely dilated outflow tracts.

The self-expanding VenusP-valve has been developed specifically for percutaneous use in the native right ventricular outflow tracts to overcome the challenge of the larger outflow tracts and can fulfil the needs of more than 85% of patients who are keen to avoid sternotomy and cardiopulmonary bypass during traditional valve replacement surgery.

The procedure was performed on two patients who were previously treated with surgical patch correction for tetralogy of Fallot. Ronald G Carere and Mounir Riahi (St Paul ‘s Hospital, Canada) agreed with Shakeel Qureshi (Evelina Children’s Hospital, Great Britain) and Gejun Zhang (Fuwai Hospital, China) that these patients were more at risk of reventriculotomy, and the currently available transcatheter pulmonary valve products were not suitable for these cases. The expert team selected the VenusP-Valve as the most suitable device to serve this unmet need. Carere said: “The VenusP-Valve performed beautifully and has a simple to operate delivery system. We are very happy to have this device in our centre, and we look forward to having it widely available in Canada.”

In recent years, the transcatheter artificial heart valve systems developed by Venus Medtech have been attracting more and more attention worldwide. The upcoming VenusP-Valve global multicentre clinical trial has received more than 200 applications from nearly 30 countries worldwide. The VenusP-Valve was first implanted in Canada, marking the official entry into the North American market, and the company is expected to officially launch the FDA clinical trial in 2019.